This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,339
solution for injection subcutaneous
solution for injection subcutaneous
Cullman Research Center- Site Number : 8400001
Cullman, Alabama, United States
Shoals Primary Care - Sheffield- Site Number : 8400015
Sheffield, Alabama, United States
Chandler Clinical Research Trials- Site Number : 8400147
Chandler, Arizona, United States
Pulmonary Associates - Deer Valley Office- Site Number : 8400155
Phoenix, Arizona, United States
Medical Advancement Center of Arizona (MACOA)- Site Number : 8400130
Phoenix, Arizona, United States
Rate of change from week 8 to week 52 on post-BD FEV1 slope in FeNO population
Rate of change from week 8 to week 52 on post-bronchodilator (BD) forced expiratory volume in one second (FEV1) slope in FeNO population.
Time frame: Week 8 to Week 52
Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population
Rate of change from week 8 to week 52 on post-BD FEV1 slope in the Total population.
Time frame: Week 8 to Week 52
Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population
Rate of change from week 8 to week 104 on post-BD FEV1 slope in the FeNO population.
Time frame: Week 8 to Week 104
Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations
Change from baseline to week 52 in pre-BD FEV1 in FeNO and Total populations.
Time frame: Baseline to Week 52
Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations
Change from baseline to week 52 in post-BD FEV1 in FeNO and Total populations.
Time frame: Baseline to Week 52
Annualized severe exacerbation rate during the 52-week period in FeNO and Total populations
Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Time frame: Baseline to Week 52
Change from baseline to week 52 in fractional exhaled nitric oxide (FeNO) levels in FeNO and Total populations
Change from baseline to week 52 in FeNO levels in FeNO and Total populations.
Time frame: Baseline to Week 52
Change from baseline to week 52 in Asthma Control Questionnaire 7 items (ACQ-7) in FeNO and Total populations
ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.
Time frame: Baseline to Week 52
Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations
Change from baseline to week 52 in pre-BD FEV1 % predicted in FeNO and Total populations.
Time frame: Baseline to Week 52
Change from baseline to week 52 in Forced Vital Capacity (FVC) in FeNO and Total populations
Change from baseline to week 52 in FVC in FeNO and Total populations.
Time frame: Baseline to Week 52
Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population
Rate of change from week 8 to week 104 on post-BD FEV1 slope in Total Population.
Time frame: Week 8 to Week 104
Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations
Change from baseline to week 104 in pre-BD FEV1 in FeNO and Total populations.
Time frame: Baseline to Week 104
Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations
Change from baseline to week 104 in post-BD FEV1 in FeNO and Total populations.
Time frame: Baseline to Week 104
Annualized severe exacerbation rate during the 104-week period in FeNO and Total populations
Exacerbation defined as a deterioration of asthma requiring use of systemic corticosteroids for ≥3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Time frame: Baseline to Week 104
Change from baseline to week 104 in FeNO levels in FeNO and Total populations
Change from baseline to week 104 in FeNO levels in FeNO and Total populations.
Time frame: Baseline to Week 104
Change from baseline to week 104 in ACQ-7 in FeNO and Total populations
ACQ-7 was designed to measure both the adequacy of asthma control and change in asthma control. A global score ranges between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control.
Time frame: Baseline to Week 104
Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations
Change from baseline to week 104 in pre-BD FEV1 % predicted in FeNO and Total populations.
Time frame: Baseline to Week 104
Change from baseline to week 104 FVC in FeNO and Total populations
Change from baseline to week 104 FVC in FeNO and Total populations.
Time frame: Baseline to Week 104
Change from baseline to week 52 in Asthma Quality Of Life Questionnaire with Standardized Activities (AQLQ(S)) in FeNO and Total populations
The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.
Time frame: Baseline to Week 52
Change from baseline to week 104 in AQLQ(S) in FeNO and Total populations
The AQLQ (S) was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to patients as a result of their asthma. A global score is calculated ranging from 1 to 7. Higher scores indicate better quality of life.
Time frame: Baseline to Week 104
Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations
Rate of change from week 8 to week 156 on post-BD FEV1 slope in FeNO and Total populations.
Time frame: Week 8 to Week 156
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Incidence of TEAEs and SAEs.
Time frame: Baseline to Week 168
Incidence of adverse events of special interest (AESIs)
Incidence of AESIs.
Time frame: Baseline to Week 168
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Del Sol Research Management - Tucson- Site Number : 8400017
Tucson, Arizona, United States
Kern Allergy and Medical Research- Site Number : 8400037
Bakersfield, California, United States
Vitality Clinical Research- Site Number : 8400142
Beverly Hills, California, United States
Ascada Research - Fullerton- Site Number : 8400076
Fullerton, California, United States
Allergy and Asthma Specialists Medical Group- Site Number : 8400162
Huntington Beach, California, United States
...and 239 more locations